BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 22114849 · Received May 30, 2025

    Report

    Report Number
    3005075696-2025-00270
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 30, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A3) THIS VALUE REPRESENTS THE MAJORITY SEX OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A2/A4) THE WEIGHT AND AGE OF THE PATIENTS WAS NOT PROVIDED. A1) PATIENT IDENTIFIER(S) WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE IN WHICH THE MANUSCRIPT WAS PRESENTED AS THE EVENT DATES WERE NOT PROVIDED IN THIS LITERATURE MANUSCRIPT. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE MANUSCRIPT. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION AS THE MANUSCRIPT WAS NOT PUBLISHED AT THE TIME OF REPORT. DOI WAS UNAVAILABLE AS THIS WAS AN UNPUBLISHED MANUSCRIPT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CITATION: SULLIVAN, MARGARET L., ET AL. BOSTON, 2025. UNDERSTANDING TECHNICAL DIFFICULTIES AND RECOGNIZED ERRORS IN PEDIATRIC ROBOTIC SPINE SURGERY HYPOTHESIS: INTRA-OPERATIVE TECHNICAL CHALLENGES EXIST WITH ADOPTION OF ROBOTICS COUPLED WITH NAVIGATION (RCN), THESE CAN BE RECOGNIZED AND RESOLVED WITHOUT SIGNIFICANT CONSEQUENCES TO PATIENT CARE. STUDY DESIGN: LEVEL I: PROSPECTIVE MULTICENTER SURGICAL OUTCOMES REGISTRY INTRODUCTION: RCN IN POSTERIOR SPINAL FUSION IS INCREASING IN PREVALENCE, AND LITERATURE SUPPORTS ITS VALUE FOR SAFE AND ACCURATE PEDICLE SCREW PLACEMENT. THIS STUDY PRESENTS THE FIRST MULTI INSTITUTIONAL ANALYSIS OF TECHNOLOGICAL DIFFICULTIES IN PEDIATRIC ROBOTIC SPINE SURGERY. METHODS: DATA COLLECTED FROM A MULTICENTER PERSPECTIVE REGISTRY INCLUDED: PATIENT DEMOGRAPHICS, DISEASE ETIOLOGY, AND CLINICAL AND SURGICAL CHARACTERISTICS. THE DIFFICULTIES WERE CATEGORIZED AS: LOSS OF REGISTRATION, LOSS OF CALIBRATION, INABILITY TO PERFORM TRAJECTORY, SCREW MALPOSITION, AND SYSTEM MALFUNCTION. GENERALIZED ESTIMATED EQUATIONS (GEE) WERE USED TO QUANTIFY RCN TECHNICAL DIFFICULTIES AND IDENTIFY ASSOCIATIONS WITH CLINICAL FACTORS AND PROCEDURAL METRICS. RESULTS: 553 PATIENTS WERE INCLUDED IN THE STUDY (66% FEMALE, 61% IDIOPATHIC DIAGNOSIS, MEDIAN BMI 21). MEDIAN PREOPERATIVE COBB ANGLE (SCOLIOSIS ONLY) WAS 60°, WITH A MEDIAN OF 10 LEVELS FUSED AND 10 ROBOTIC SCREWS PLACED PER PATIENT. INTRAOPERATIVE TECHNICAL DIFFICULTIES WERE ENCOUNTERED IN 148 PATIENTS (27%). THE MOST FREQUENT WERE INABILITY TO PERFORM TRAJECTORY (9%), LOSS OF REGISTRATION (8%), AND LOSS OF SYSTEM CALIBRATION (6%) (TABLE 1). OF 6739 RCN-PLACED SCREWS, 31 (0.4%) WERE MALPOSITIONED: ALL RECOGNIZED AND REDIRECTED INTRAOPERATIVELY. ONE INSTANCE (0.2%) OF DURAL INJURY WAS RECORDED. PATIENTS WITH TECHNICAL DIFFICULTIES HAD LARGER PREOPERATIVE COBB ANGLES (MEDIAN 64° VS. 59°; P=0.009) AND UNDERWENT FUSION OF MORE VERTEBRAL LEVELS (MEDIAN 11 VS. 10; P=0.003). INCREASED BMI WAS ASSOCIATED WITH HIGHER ODDS OF TECHNICAL DIFFICULTIES; SPECIFICALLY, 173%, 88%, AND 44% HIGHER ODDS OF INABILITY TO PERFORM TRAJECTORY, SCREW MALPOSITION, AND LOSS OF CALIBRATION, RESPECTIVELY (ALL P 0.05). TECHNICAL DIFFICULTIES DID NOT SIGNIFICANTLY AFFECT EBL (P=0.4) OR OPERATIVE TIME (P=0.06). NO RETURNS TO THE OPERATING ROOM OR NEUROLOGIC DEFICITS RESULTED FROM TECHNICAL DIFFICULTIES. CONCLUSION: TECHNICAL DIFFICULTIES IDENTIFIED HERE WERE RECOGNIZED AND RESOLVED INTRAOPERATIVELY, PREVENTING ADVERSE CONSEQUENCES TO PATIENTS. MORE LEVELS FUSED, HIGHER BMI, LARGER COBB ANGLES, AND SYNDROMIC DIAGNOSES INCREASED THE LIKELIHOOD OF TECHNICAL DIFFICULTIES. REPORTABLE EVENTS: SCREW MALPOSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21270 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female